Vermox 100mg/5ml Suspension

VERMOX u00ae suspension is indicated for the treatment of single and mixed helminth gastrointestinal infestations caused by:

• Nematodes such as:
• Trichuris trichiura (whipworm)
• Ancylostoma duodenale (hookworm)
• Necator americanus (hookworm)
• Ascaris lumbricoides (large roundworm)
• Ternidens deminutus
• Enterobius vermicularis (pinworm)
• Strongyloides stercoralis (threadworm)
• Cestodes such as:
• Taenia spp. (tapeworm)
• Infestations by Moniliformis moniliformis

Whipworm; hookworm; large roundworm; Pinworm; Ternidens deminutus; infestations by Moniliformis moniliformis:

One medicine measure (5 mL) twice daily (morning and evening) for three consecutive days. This standard dosage applies to adults, children and infants over the age of 1 year.

Whipworm; Hookworm; Large Roundworm and Pinworm:

25 mL given as a single dose. This dosage applies only to adults and children older than 1 year.

Tapeworm (Taenia spp.):

One medicine measure (5 mL) twice daily (morning and evening) for six consecutive days. This standard dosage applies to adults, children and infants.

Threadworm (Strongyloides stercoralis):

Adults: Two medicine measures (10 mL) twice daily (morning and evening) for three consecutive days.

Children: One medicine measure (5 mL) twice daily (morning and evening) for three consecutive days.

A second course of treatment should be given to those patients who are still infected three to four weeks after the first course.

In worm-eradication campaigns the standard course should be administered every quarter during the first year.

If a helminth is not susceptible to the standard dosage, a treatment course of longer than three days and/or involving higher doses than 5 mL for suspension is recommended.

The efficacy of VERMOX u00ae suspension is dependent upon the duration of physical contact between the medicine and parasite. When gastrointestinal transit time is accelerated, e.g. in diarrhoea, it is necessary to repeat the dose at more frequent intervals daily.

For infants under 1 year of age, see sections 4.3 and 4.4.

Instructions for use of VERMOX u00ae suspension: Shake the bottle before use. The bottle comes with a child-proof cap, and should be opened as follows:

1. Push the plastic screw cap down
2. While pressing down, turn the cap counterclockwise.

VERMOX u00ae suspension should not be used in children below the age of 1 year.

VERMOX u00ae suspension is contraindicated in persons with a known hypersensitivity to mebendazole or to any of the other ingredients in VERMOX u00ae suspension (see section 6.1).

VERMOX u00ae suspension should not be given during pregnancy, as it is teratogenic in animals (see section 4.6).

Concomitant use of mebendazole and metronidazole should be avoided (see sections 4.4 and 4.5).

Convulsions in children, including in infants below one year of age, have been reported during post-marketing experience with VERMOX u00ae suspension (see section 4.8). VERMOX u00ae suspension should not be given to children below 1 year of age. VERMOX u00ae suspension should only be given to very young children if their worm infections interfere significantly with their nutritional status and the physical development.

There have been reports of reversible liver function disturbances, hepatitis, neutropenia, agranulocytosis and glomerulonephritis described in patients who were treated with dosages substantially above those recommended for prolonged periods of time (see section 4.9).

Results from a case control study investigating an outbreak of Stevens Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) indicated a possible relationship between SJS/TEN and the concomitant use of VERMOX u00ae suspension and metronidazole. Further data on interactions are not available. Therefore, concomitant use of VERMOX u00ae suspension and metronidazole should be avoided (see section 4.3 and 4.5).

Sucrose: VERMOX u00ae suspension contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take VERMOX u00ae suspension.

Methylparaben and propylparaben: VERMOX u00ae suspension contains methylparaben and propylparaben which may cause an allergic reaction (possibly delayed).

Concomitant treatment with cimetidine may inhibit the metabolism of mebendazole in the liver, resulting in increased plasma concentrations of VERMOX u00ae suspension especially during prolonged treatment.

Concomitant use of VERMOX u00ae suspension and metronidazole should be avoided (see sections 4.3 and 4.4).

Pregnancy: VERMOX u00ae suspension is contraindicated during pregnancy (see section 4.3). Mebendazole has shown embryotoxic and teratogenic activity in rats and in mice at single oral doses.

Lactation: Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. VERMOX u00ae suspension is therefore not recommended during lactation.

Fertility: The effect of mebendazole on human fertility has not been evaluated.

VERMOX u00ae suspension can cause side effects such as dizziness. Patients are advised not to drive a vehicle or operate machinery until they know how treatment with VERMOX u00ae suspension affects them.

Patients with high parasitic burdens when treated with VERMOX u00ae suspension have manifested diarrhea and abdominal pain.

Clinical trial data: The safety of VERMOX u00ae suspension was evaluated in 6276 subjects who participated in 39 clinical trials for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical trials, no adverse drug reactions (ADRs) occurred in u2265 1 % of VERMOX u00ae suspension-treated subjects. ADRs occurring in u2264 1 % of VERMOX u00ae -treated subjects are shown below.

Blood and the lymphatic system disorders:

• Very rare: agranulocytosis (higher and prolonged doses)

Nervous system disorders:

• Rare: dizziness

Gastrointestinal disorders:

• Common: abdominal pain
• Uncommon: abdominal discomfort, diarrhoea, flatulence

Skin and subcutaneous tissue disorders:

• Rare: rash

Post-marketing:

Blood and the lymphatic system disorders:

• Rare: neutropenia

Immune system disorders:

• Rare: hypersensitivity including anaphylactic reaction and anaphylactoid reaction

Nervous system disorders:

• Rare: convulsions

Gastrointestinal disorders:

• Very rare: nausea, vomiting

Hepato-biliary disorders:

• Rare: hepatitis, abnormal liver function tests

Skin and subcutaneous tissue disorders:

• Rare: toxic epidermal necrolysis, Stevens Johnson syndrome, exanthema, angioedema, urticaria, alopecia

Renal and urinary disorders:

• Very rare: glomerulonephritis (higher and prolonged doses)

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of VERMOX u00ae suspension is important. It allows continued monitoring of the benefit/risk balance of VERMOX u00ae suspension. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported: alopecia, reversible liver function disturbances, hepatitis, agranulocytosis, neutropenia and glomerulonephritis. With the exception of agranulocytosis and glomerulonephritis, these also have been reported in patients who were treated with mebendazole at standard dosages.

Symptoms: In the event of accidental overdose, abdominal cramps, nausea, vomiting and diarrhoea may occur.

Treatment: There is no specific antidote. If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced and such symptomatic supportive therapy be administered as appears indicated. Activated charcoal may be given.